FDAFDA · Food and drugs·Recall number D-0855-2017
SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-044-01
Published May 31, 2017 · Recall initiated: February 16, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sato Pharmaceutical Inc.
- Distributor
- US: Hawaii, Guam, Saipan, SPI
- Lot
- Lot #: WXWZ, Exp. March 2019; WXTS, Exp. October 2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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